Expert: Michael Anisfeld - 3/20/2008

Question
Hi
What is the significance of testing endotoxins in parentral preperation .the normal limit is found 0.25EU/ml ..will excess may cause problems...and in case of anticoagulants the limit is 5.65 EU/ml ..and in medical devices limit is more ...why it is so...
Sreejith

Answer
The presence of endotoxins can cause a cascade of body reactions/degradations leading to death (documented as being within 45 minutes of injection). The pharmacopoeal limits for injectables (0.25EU/mL) are set at a level that is below that causing body reaction.

other products have different limits based on the reality of the product. Most endotoxins are bacterial degradation products, but some chemicals (such as anti-coagulants) have there own inherent endotoxin impact - hence the different limits.